House berates FDA, drug makers

US Congressional subcommittee holds hearing on clinical trial disclosure rules

Alicia Ault(afault@yahoo.com)
Sep 9, 2004

At a day-long hearing in Washington, DC, yesterday (September 9), the House Energy and Commerce Subcommittee on Oversight and Investigations repeatedly took both Food and Drug Administration (FDA) and pharmaceutical company officials to task for failing to fully disclose clinical trial results.

The charge was led by committee chairman Rep. Joe Barton (R-Texas), a long-time FDA critic. Barton chided the agency for stonewalling committee requests for more data on studies of antidepressants in children, saying that FDA "actually stands for 'foot-dragging and alibis.'"

The subcommittee's ongoing investigation of what has–or has not–been disclosed about these drugs' efficacy and side effects was the hearing's main focus. But panelists also closely questioned FDA and drug company witnesses about whether they intended to support various proposals to create centralized registries and databases that would contain both positive and negative trial results.

Janet Woodcock, FDA's acting deputy commissioner for operations, said, "I strongly support...

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